MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-05-15 for GETINGE 46-SERIES 46-4 manufactured by Getinge Disinfection Ab.
[16436595]
An overheating was reported in a 46-4 washer disinfector in the lower side of the chamber during the drying phases. After some time it escalated into fire. The machines outer panel plates contained the fire and protected the surrounding materials. The operator turned off the main switch and used an extinguisher to put out the fire. Smoke spread to nearby rooms. One person reported throat pain from the smoke and the extinguisher.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616031-2013-00001 |
| MDR Report Key | 3134147 |
| Report Source | 07 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-04-15 |
| Date Mfgr Received | 2013-04-16 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2013-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN WHEELER, US AGENT |
| Manufacturer Street | 1777 E. HENRIETTA ROAD |
| Manufacturer City | ROCHESTER NY 14623 |
| Manufacturer Country | US |
| Manufacturer Postal | 14623 |
| Manufacturer Phone | 5852725036 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 |
| Manufacturer City | VAXJO 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 351 15 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GETINGE 46-SERIES |
| Generic Name | WASHER DISINFECTOR |
| Product Code | MDZ |
| Date Received | 2013-05-15 |
| Model Number | 46-4 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO 35115 SW 351 15 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-15 |